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Not Yet Recruiting NCT07874802

An AI-powered Virtual Reality Brief Intervention for Hospitalized Patients With Alcohol-Associated Liver Disease (SOBER-VR)

Conditions: Alcohol-associated Liver Disease

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1
Enrollment: 30
Sponsor: The Cleveland Clinic

Summary

Alcohol-associated liver disease (ALD) is a leading cause of preventable liver-related morbidity and mortality, with hospitalizations for ALD increasing significantly in recent years. Many patients with ALD and active alcohol use disorder (AUD) are discharged from the hospital without receiving evidence-based behavioral interventions, despite hospitalization representing a teachable moment when patients may be more motivated to change. Psychosocial support in this setting is often limited by short inpatient stays, provider shortages, and workflow barriers. Novel digital health approaches are needed to increase access to structured, personalized behavioral support during hospitalization. This project aims to assess the feasibility, usability, and clinical relevance of SOBER-VR, a virtual reality (VR) and artificial intelligence (AI)-powered digital therapeutic that delivers motivational interviewing (MI) to hospitalized patients with ALD and active alcohol use. SOBER-VR uses immersive VR to enhance emotional salience and a large language model (LLM)-driven conversational agent to simulate reflective, MI-consistent interactions. The intervention is brief (10-15 minutes), self-guided, and delivered using sanitized, standalone VR headsets with real-time support from trained staff. Using the NIH ORBIT Model for behavioral intervention development, this Phase Ib single-arm feasibility study will recruit 30 hospitalized patients with ALD and active alcohol use. Participants will use SOBER-VR during their inpatient stay and complete structured assessments post-discharge. The study will evaluate feasibility (recruitment, engagement, and retention), acceptability, usability, and safety of SOBER-VR. Preliminary signals of clinical impact, such as readiness to change, attitude to AUD treatment, among others, will also be explored.

Eligibility Criteria

Inclusion Criteria: * 18+ years of age * Patients with lived experience of inpatient admissions due to ALD OR a Cleveland Clinic nurse (with experience in healthcare quality) * English-speaking Exclusion Criteria: * Unwilling and/or unable to participate * Non-English speakers * Delirium/acute encephalopathy prevents safe participation * Self-reported history of acute and/or severe motion sickness * The presence of a facial/head deformity that will prohibit the wearing of a VR HMD * Legally blind or deaf * Having had a seizure in the past year * Those who are pregnant

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07874802). StuddyBuddy aggregates publicly available trial information.